[Federal Register Volume 59, Number 95 (Wednesday, May 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12031]


[[Page Unknown]]

[Federal Register: May 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
 

Office of the Assistant Secretary for Health; Privacy Act of 
1974; Altered System of Records

AGENCY: Public Health Service, HHS.

ACTION: Notification of an altered system of records.

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SUMMARY: In accordance with the requirements of the Privacy Act, the 
Public Health Service (PHS) is publishing a notice of a proposal to 
alter system of records 09-37-0151, Public Health Service ALERT Records 
Concerning Individuals Found to Have Committed Scientific Misconduct in 
PHS Sponsored Research, HHS/OASH/ORI. This system of records has been 
transferred from the National Institutes of Health to the Office of 
Research Integrity, Office of the Assistant Secretary for Health, 
Public Health Service.
    The purpose of altering this system of records is to automate the 
system of records so that storage will be on computer disks as well as 
hard copy. In addition, ORI is proposing to maintain the social 
security numbers of the individuals in the system of records solely to 
confirm the identify of the subjects of the records.

DATES: PHS invites interested persons to submit comments on the 
proposed alterations on or before June 27, 1994. PHS has sent a Report 
of Altered System to the Congress and to the Office of Management and 
Budget on May 6, 1994. The alteration of this system of records will be 
effective 60 days from the date submitted to OMB, unless PHS receives 
comments which result in a contrary determination.

ADDRESS: Comments should be addressed to the ORI Privacy Act Officer at 
the address listed below. Comments received will be available for 
inspection from 9 a.m. to 3 p.m.

FOR FURTHER INFORMATION CONTACT:
Privacy Act Officer, Office of Research Integrity, Rockwall II, suite 
700, 5515 Security Lane, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: PHS proposes to alter this system of 
records, 09-37-0151, ALERT Records Concerning Individuals Found to Have 
Committed Scientific Misconduct in PHS Sponsored Research, HHS/OASH/
ORI, principally by changing the method of Storage of the records from 
hard copy to one that includes storage on computer disks.
    This system was maintained by NIH. The system name has been changed 
to more accurately describe the records in the system. The number and 
title has been changed from 09-25-0151, Administration: ALERT Records 
Concerning Individuals under Investigation for Possible Misconduct in 
Science or Subject to Sanction for Such Misconduct to ``09-37-0151. 
ALERT Records Concerning Individuals Found to Have Committed Scientific 
Misconduct in PHS Sponsored Research.''
    PHS also proposes to maintain the Social Security numbers of the 
subjects of the records. The character, scope and operation of the 
system will remain the same. The Division of Policy and Education, ORI 
will continue to maintain this system of records and will control 
disclosures, as appropriate.
    The change in the method of storage will provide a more effective 
way for ORI to perform its responsibilities in the award of funds for 
scientific research and development. Automating the system will provide 
more effective means of communicating necessary information between 
agencies. Social Security numbers will be used solely for the purpose 
of correctly identifying the subjects of the investigation. In those 
instances when the SSN is not available, the date of birth will be 
utilized.
    This system has had minor modifications since the last publication 
of the system notice. These changes were to the System Name and Number, 
Categories of Individuals Covered by the System, Categories of Records 
in the System, Purposes of the System, Safeguards, System Manager(s) 
and Address. They are as follows:
    The change in the System Number and Name described above was made 
to more accurately describe the records in the system.
    The Categories of Individuals covered by the system has been 
narrowed. The PHS ALERT no longer contains the names of individuals who 
are subject to an investigation of scientific misconduct or where there 
has been a determination that misappropriation of federal research 
funds had occurred.
    Individuals may be the subject of the records if they fall within 
the following categories:
    (1) ORI has made a finding of scientific misconduct concerning the 
individual; (2) the individual is the subject of an administrative 
action imposed as a result of a determination that scientific 
misconduct has occurred; (3) the Individual has agreed to voluntary 
corrective action as result of an investigation of scientific 
misconduct; (4) ORI has received a report of an investigation by an 
institution in which there was a finding of scientific misconduct 
concerning the individual and ORI has determined that PHS has 
jurisdiction; (5) FDA has determined that there is sufficient reason to 
believe that official action is warranted against the individual for 
violation of an FDA regulation governing research.
    In addition, the following changes have been made to the system of 
records:
    The Categories of Records in the system has been changed to more 
accurately reflect the information that is maintained in the system.
    The Purpose section has been changed in a way that it remains 
compatible with the previous published purposes. We have added a 
section that deals with those instances in which the information in the 
system may be used.
    The Safeguards section has been altered as necessary to assure that 
the records are maintained in a secure manner compatible with their 
content and purposes.
    The System Manager and address section has been changed to reflect 
changes in the internal organizational structure of the ORI and its 
procedures.
    Additionally, PHS has made a number of editorial changes throughout 
the system notice to clarify and to accommodate normal updating 
changes.
    The four routine uses for this system are compatible with the 
stated purposes of the system. The first routine use allows referral to 
the appropriate official(s) of the awardee institution or organization 
when in connection with an ORI review of an institution's investigation 
or finding of scientific misconduct by an individual employed by or 
affiliated with the institution or organization, a PHS agency is taking 
an action affecting research and research training awards to that 
institution or organization. The second routine use proposed for this 
system permits disclosure to a congressional office to allow the 
subject individuals to obtain assistance from their representatives in 
Congress, should they so desire. Such disclosure would be made only 
pursuant to a request from the subject of the record. The third routine 
use allows disclosure to the Department of Justice, a court, or 
administrative tribunal in the event of litigation. The fourth routine 
use allows disclosure by way of an electronic bulletin board to outside 
organizations and institutions of investigative findings and 
administrative actions when scientific misconduct is found. This 
disclosure will provide information that will enable the institutions 
and organizations to enforce PHS administrative actions within their 
institution or organization.
    This system notice is written in the present, rather than the 
future tense, to avoid the unnecessary expenditure of public funds to 
republish the notice after the notice becomes effective.

    Dated: May 9, 1994.
Wilford J. Forbush,
Director, Office of Management.
09-37-0151
    Public Health Service ALERT Records Concerning Individuals Found to 
Have Committed Scientific Misconduct in PHS Sponsored Research, HHS/
OASH/ORI.
    None.
    Office of Research Integrity, Public Health Service, Rockwall II, 
suite 700, 5515 Security Lane, Rockville, Maryland 20852.
    Subjects may include (1) researchers currently or formerly employed 
by the Federal Government; (2) individuals being considered for 
appointment to Public Health Service (PHS) advisory committees; (3) 
investigators on research grants, fellowships, cooperative agreements, 
or contracts awarded by any PHS agency, (``Investigators'' may include 
principal investigators, co-investigators, program directors, trainees, 
recipients of career awards or fellowships, or other individuals who 
conduct or are responsible for research or research training funded by 
PHS); (4) research investigators, such as guest workers, not employed 
by PHS but who conduct research in PHS facilities or are closely 
associated with research conducted by PHS; (5) other individuals, such 
as subgrantees, subcontractors or assistants on research or research 
training grants, contracts or cooperative agreements, who by training, 
experience, occupation or other qualifications are potential candidates 
for research or research training grants, contracts, cooperative 
agreements or other benefits.
    Such individuals would be subjects of records in this system if 
they fall within the following categories:
    (1) ORI has made a finding of scientific misconduct concerning the 
individual;
    (2) The individual is the subject of administrative actions imposed 
as a result of a determination that scientific misconduct has occurred. 
Such administrative actions include but are not limited to: (a) 
Restrictions on specific activities or expenditures under an active 
award, (b) a requirement for special reviews of all requests for 
funding; (C) actions affecting eligibility for appointment as an 
individual or member of a committee providing advice to PHS; (d) 
debarment from participation in covered transactions which may include 
grants, contracts, and cooperative agreements; (e) suspension or 
termination of an active award; (f) special restrictions on regulated 
research, such as disqualification by the Food and Drug Administration 
(FDA) from use of investigational drugs or other products, or other 
restrictions place on such use; and (g) termination of employment or 
other disciplinary action against an employee of PHS.
    (3) The individual has agreed to a voluntary corrective action as a 
result of an investigation of scientific misconduct.
    (4) ORI has received a report of an investigation by an institution 
in which there is a finding of scientific misconduct concerning the 
individual and ORI has determined that PHS has jurisdiction.
    (5) The FDA has determined after an investigation that there is 
sufficient reason to believe that official action is warranted against 
the individual for violation of FDA regulations governing research.
    This system contains records relating to findings of scientific 
misconduct and to actions that PHS has taken in connection with such 
findings including voluntary exclusion agreements. This information is 
limited to (1) the ORI Case Reference number, (2) the name of the 
subject of the investigation, (3) the individual's social security 
number, (4) the date of birth of the individual, (5) the type of 
misconduct, (6) the institution that conducted the investigation, (7) a 
summary of the administrative actions imposed as a result of the 
misconduct and the effective and expiration dates, (8) the involved PHS 
support and the involved PHS agencies or funding components including 
identification of the specific office responsible for the 
investigation, (9) the record creation date, and (10) the last entry 
date. Scientific misconduct is defined as fabrication, falsification, 
plagiarism or other practices that seriously deviate from those that 
are commonly accepted within the scientific community for proposing, 
conducting or reporting research. It does not include honest error or 
differences in interpretations or judgement of data.
    Authority for this system comes from the legislation which 
authorizes PHS to make awards for biomedical and behavioral research 
and research training, and from PHS's concomitant responsibility to 
assure both that funds disbursed under awards are spent for authorized 
purposes and that recipients of such funds conform to all appropriate 
laws and regulations. (5 U.S.C. 301; 29 U.S.C. 669; 42 U.S.C. 241, 
242b, 242c, 2421, 242m, 247c, 281-289h, 285n, 285n-2, 285o, 285o-2, 
300a-2, 300b-1-b-3, 300c-12, 300z-7, as these provisions relate to 
biomedical and behavioral research and research training).
    This system of records enables PHS agencies to discharge 
effectively their responsibilities in the award and administration of 
research and training grants, cooperative agreements and contracts, 
while protecting the privacy and other rights of individuals. The PHS 
ALERT system is used to collect, control and disseminate to PHS agency 
officials on a need-to-know basis information that: (1) The PHS has 
made a finding of scientific misconduct or (2) the PHS has imposed 
administrative action(s) at the conclusion of an investigation for 
scientific misconduct; or (3) has received a report of an investigation 
by an institution in which there is a fining of scientific misconduct 
and ORI has determined that the PHS has jurisdiction, or (4) the FDA 
has determined after an investigation that there is sufficient reason 
to believe that official action is warranted against such persons for 
violation of FDA regulations governing research or (5) an individual 
has agreed to a voluntary corrective action relative to findings of 
scientific misconduct.
    Specifically,
    (1) PHS records the existence of such administrative actions in the 
system so that PHS agencies can track and implement the administrative 
actions, for example by refusing to accept an application or proposal 
from a debarred person. In addition, PHS informs members of technical 
merit review groups of actions taken if the disclosure is necessary to 
ensure an unbiased review by providing an accurate account of the case, 
for example, when information concerning the conduct investigated has 
been disclosed by other sources, such as the press or other 
communications media.
    (2) The ORI will transmit the names and, if available, the SSN or 
date of birth of those individuals against whom there was a finding of 
scientific misconduct and administrative action(s) to the Division of 
Research Grants (DRG), National Institutes of Health (NIH) and to other 
appropriate officials within the PHS. DRG will use this file to screen 
automatically PHS research contract and grant award records; 
applications for PHS funding of research grants, fellowships and 
cooperative agreements; and nominations/appointments to PHS advisory 
committees.
    (3) If the ORI's review of the institutional investigation findings 
or the Departmental Appeals Board (DAB) hearing on the findings fail to 
confirm misconduct (a) the individual's name is removed from the PHS 
ALERT system of records and the individual is notified in writing; (b) 
responsible PHS agency officials are notified of the outcome; (c) if 
any interim administrative actions had been imposed, they are 
withdrawn.
    (4) Appropriate agency officials are notified of additions to the 
PHS ALERT for the purpose of communicating and disseminating 
information about scientific misconduct.
    (5) PHS Committee Management Officers are notified of 
administrative actions restricting or prohibiting PHS advisory service 
in order to assist in the appointment of candidates for the advisory 
committees.
    (6) Upon request, the System Manager may disclose information to 
PHS agency officials who are considering hiring a subject individual.
    (7) Upon request, the System Manager may disclose information in 
the PHS ALERT to contracting officers in order to assist them in the 
award of a contract.
    1. PHS may notify responsible officials of the awardee institutions 
or organizations when, in connection with an ORI review of an 
institution's investigation or a finding of scientific misconduct by an 
individual employed by or affiliated with the institution or 
organization, a PHS agency takes an action affecting research and 
research training awards to the institution or organization. 
Information disclosed will be limited to the name of the subject 
individual, description of the action and the reason for it.
    2. Disclosure may be made to a congressional office from the record 
of an individual in response to an inquiry from the congressional 
office made at the request of that individual.
    3. Disclosure may be made from this system of records to the 
Department of Justice, or to a court or other tribunal, when (a) HHS, 
or any component thereof; or (b) any HHS employee in his or her 
official capacity or (c) any HHS employee in his or here individual 
capacity where the Department of Justice, (or HHS, where it is 
authorized to do so) has agreed to represent the employee; or (d) the 
United States or any agency thereof where HHS determines that the 
litigation is likely to affect HHS or any of its components is a party 
to litigation, and HHS determines that the use of such records by the 
Department of Justice, court or other tribunal is relevant and 
necessary to the litigation and would help in the effective 
representation of the governmental party, provided, however, that in 
each case, HHS determines that such disclosure is compatible with the 
purpose for which the records were collected.
    4. Disclosure may be made via an electronic bulletin board to 
institutions, organizations and persons connected to the electronic 
bulletin boards outside the DHHS and components within the DHHS of the 
names of individuals against whom there was a finding of scientific 
misconduct and an imposition of administrative actions including 
voluntary exclusion agreements. The information will enable applicant 
institutions to enforce PHS administrative actions within their 
institutions.
    Records are stored in file folders and computer disks.
    Records are retrieved by name of the individual who is the subject 
of an ORI investigation or review of an institution's investigation or 
subject to an administrative action.
    1. Authorized users: Records are available only to the system 
manager, Director of Division of Policy and Education (DPE), ORI, or 
designee. Any disclosure to other individuals must be authorized by the 
Director, DPE.
    2. Procedural safeguards: Access to records is strictly controlled 
by the system manager and the officials specified under ``Authorized 
Users.'' Individuals who receive disclosures from this system before 
there is a final agency finding, are informed that the information is 
confidential.
    3. Physical safeguards: Sensitive records stored in file folder and 
on computer discs are kept in locked file cabinets in areas which are 
locked when not in use. Special measures, commensurate with the 
sensitivity of the records, are taken to prevent unauthorized copying 
or disclosure of records.
    These practices are in compliance with the standards of chapter 45-
13 of the HHS General Administration Manual, ``Safeguarding Records 
contained in Systems of Records,'' supplementary Chapter PHS hf: 45-13, 
and the Department's Automated Information System Security Handbook.
    Records are retained and disposed of in accordance with the OASH 
Records Control Schedule. If an institutional finding of scientific 
misconduct is reversed by ORI or DAB, the PHS ALERT records are 
destroyed. If an investigation results in an official administrative 
action or voluntary exclusion agreements, a record of such 
administrative action is maintained for the duration of the 
administrative action and then destroyed.
    PHS ALERT System Manager, Division of Policy and Education, Office 
of Research Integrity, Rockwall II, suite 700, 5515 Security Lane, 
Rockville, MD 20852.
    Individuals are routinely notified in writing when they become the 
subject of a record in this system, unless a law enforcement agency has 
instructed PHS not to do so. Subject individuals are also informed 
routinely when their records are deleted from the system.
    Individuals may write to the system manager at the address above 
and provide their full name and the name of this Privacy Act system of 
records to request a copy of the record. Requesters should also 
reasonably specify the record contents being sought. Individuals may 
also request a listings of accountable disclosures that have been made 
of their records, if any.
    Individuals may write to the system manager and reasonably identify 
the record and the information being contested; and state the reasons 
for requesting the change, along with supporting information to show 
that the record is untimely, incomplete, irrelevant, or inaccurate. The 
right to contest records is limited to information which is incomplete, 
irrelevant, incorrect or untimely (obsolete).
    Information in these records is obtained from awardee institutions 
or organizations, and PHS agencies and organizations responsible for 
investigations.
    None.
[FR Doc. 94-12031 Filed 5-17-94; 8:45 am]
BILLING CODE 4168-17-M